Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsStatutory Rules No. 106, 2001
made under the
Compilation date: 26 February 2025
Includes amendments: F2025L00204
About this compilation
This compilation
This is a compilation of the Gene Technology Regulations 2001 that shows the text of the law as amended and in force on 26 February 2025 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.
Self-repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
Part 1--Preliminary
1 Name of Regulations
Part 2--Interpretation and general operation
4 Techniques not constituting gene technology
4A Organisms that are genetically modified organisms
5 Organisms that are not genetically modified organisms
Part 2A--Gene Technology Regulator
5A Functions of the Regulator
Part 3--Dealings with GMOs
Division 1--Licensing system
6 Dealings exempt from licensing
7 Application for licence--prescribed fee
8 Time limit for deciding an application
9 Prescribed authorities
9A Risks posed by dealings proposed to be authorised by licence
10 Risk assessment--matters to be taken into account
11 Prescribed conditions of licence
11A Time limit for deciding variation application
Division 2--Notifiable low risk dealings
12 Notifiable low risk dealings
13 Requirements for undertaking notifiable low risk dealings
13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
13C Information to be kept or given to the Regulator by persons or accredited organisations
Division 3--Certification and accreditation
14 Regulator to decide certification application within 90 days
15 Application for certification--failure to provide section 85 information
16 Regulator to decide accreditation application within 90 days
17 Application for accreditation--failure to provide section 93 information
Part 4--Gene Technology Technical Advisory Committee
Division 1--Conditions of appointment
18 GTTAC members and advisers--term of appointment
19 GTTAC members and advisers--resignation
20 GTTAC members--disclosure of interests
21 GTTAC members and advisers--termination of appointment
22 GTTAC members--leave of absence
23 Expert advisers--disclosure of interests
Division 2--Committee procedures
24 Committee procedures generally
25 Committee meetings
26 Presiding member
27 Quorum
28 Voting
29 Records and Reports
Division 3--Subcommittees
30 Operation of subcommittees
Part 5--Ethics and Community Committee
31 Ethics and Community Committee--conditions of appointment
32 Ethics and Community Committee--Committee procedures
33 Ethics and Community Committee--operation of subcommittees
Part 7--Miscellaneous
37 Reviewable State decisions
38 Review of decisions
39 Record of GMO Dealings
40 Inspector identity card
Part 8--Application and transitional provisions
Division 1--Amendments made by the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019
41 Changed requirements for dealings
42 Previous assessment by an Institutional Biosafety Committee
43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year
Division 2--Amendments made by the Gene Technology Amendment (Minor Measures) Regulations 2025
44 Preliminary
45 Risk assessments and risk management plans
46 Resignation of committee member or expert adviser
47 Disclosure of interests by committee member
48 Techniques that are not gene technology
49 Organisms that are not GMOs
Schedule 1A--Techniques that are not gene technology
Schedule 1B--Organisms that are genetically modified organisms
1.1 Genetically modified organisms
Schedule 1--Organisms that are not genetically modified organisms
Schedule 2--Dealings exempt from licensing
Part 1--Exempt dealings
Part 2--Host/vector systems for exempt dealings
2.1 Hosts and vectors
Part 3--Definitions
Schedule 3--Notifiable low risk dealings in relation to a GMO
Part 1--Notifiable low risk dealings suitable for at least physical containment level 1
1.1 Kinds of dealings suitable for at least physical containment level 1
Part 2--Notifiable low risk dealings suitable for at least physical containment level 2 or 3
2.1 Kinds of dealings suitable for at least physical containment level 2
2.2 Kinds of dealing suitable for at least physical containment level 3
Part 3--Dealings that are not notifiable low risk dealings
3.1 Kinds of dealings
Endnotes
Endnote 1--About the endnotes
Endnote 2--Abbreviation key
Endnote 3--Legislation history
Endnote 4--Amendment history
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1--About the endnotes
Endnote 2--Abbreviation key
Endnote 3--Legislation history
Endnote 4--Amendment history
Abbreviation key--Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history--Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history.
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub-subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev ... ) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
ed = editorial change | reloc = relocated |
exp = expires/expired or ceases/ceased to have | renum = renumbered |
effect | rep = repealed |
F = Federal Register of Legislation | rs = repealed and substituted |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | Sch = Schedule(s) |
Sdiv = Subdivision(s) | |
(md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
effect | SR = Statutory Rules |
(md not incorp) = misdescribed amendment | Sub-Ch = Sub-Chapter(s) |
cannot be given effect | SubPt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Endnote 3--Legislation history
Number and year | FRLI registration or gazettal | Commencement | Application, saving and transitional provisions |
2001 No. 106 | 31 May 2001 | 22 June 2001 (r 2) |
|
2006 No. 314 | 1 Dec 2006 (F2006L03558) | 31 Mar 2007 | r 4 |
2007 No. 128 | 24 May 2007 (F2007L01317) | Sch 1: 1 July 2007 (r 2 (a)) | -- |
2009 No. 68 | 1 May 2009 (F2009L01112) | 2 May 2009 (r 2) | -- |
2011 No. 73 | 3 June 2011 (F2011L00933) | 1 Sept 2011 (r 2) | r 4 |
Name | Registration | Commencement | Application, saving and transitional provisions |
Biosecurity (Consequential Amendments and Transitional Provisions) Regulation 2016 | 9 May 2016 (F2016L00717) | Sch 2 (item 13) and Sch 3: 16 June 2016 (s 2(1) item 1) | Sch 3 |
Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 | 8 Apr 2019 (F2019L00573) | Sch 1: 8 Oct 2019 (s 2(1) item 2) | -- |
Administrative Review Tribunal Legislation Consequential Amendments (2024 Measures No. 1) Regulations 2024 | 11 Oct 2024 (F2024L01299) | Sch 7 (items 4-6): 14 Oct 2024 (s 2(1) item 1) | -- |
Gene Technology Amendment (Minor Measures) Regulations 2025 | 25 Feb 2025 (F2025L00204) | 26 Feb 2025 (s 2(1) item 1) | -- |
Provision affected | How affected |
Part 1 |
|
r 2..................... | rep LA s 48D |
r 3..................... | rs. 2006 No. 314 |
| am. 2007 No. 128; 2011 No. 73; F2019L00573 |
Part 2 |
|
r 4..................... | rs. 2006 No. 314 |
| am F2019L00573 |
r 4A.................... | ad F2019L00573 |
r 5..................... | rs F2019L00573 |
Part 2A |
|
Part 2A.................. | ad. 2009 No. 68 |
r 5A.................... | ad No 68, 2009 |
| am No 73, 2011 |
| rs F2025L00204 |
Part 3 |
|
Division 1 |
|
r. 6..................... | am. 2006 No. 314; 2007 No. 128; 2011 No. 73 |
r. 7..................... | rs. 2006 No. 314 |
r. 8..................... | am. 2007 No. 128 |
r 9..................... | am 2006 No. 314; 2007 No. 128; F2016L00717; F2019L00573; F2025L00204 |
r. 9A.................... | ad. 2007 No. 128 |
r. 10.................... | am. 2006 No. 314 |
r. 11A................... | ad. 2007 No. 128 |
| rs. 2011 No. 73 |
Division 2 |
|
r 12.................... | am. 2011 No. 73; F2019L00573 |
r 13.................... | rs. 2006 No. 314; 2007 No. 128; 2011 No. 73 |
| am F2019L00573 |
r 13A................... | ad. 2007 No. 128 |
| rs. 2011 No. 73 |
| rep F2019L00573 |
r 13B................... | ad. 2011 No. 73 |
| am F2019L00573 |
r 13C................... | ad. 2011 No. 73 |
| am F2019L00573 |
Part 4 |
|
Division 1 |
|
r 19.................... | am F2025L00204 |
r 20.................... | am F2025L00204 |
r 21.................... | am F2019L00573; F2024L01299 |
Division 2 |
|
r 26.................... | am F2019L00573 |
Division 3 |
|
r. 29.................... | am. 2006 No. 314 |
Part 5 |
|
Part 5................... | rs. 2007 No. 128 |
r. 31.................... | rs. 2007 No. 128 |
r 32.................... | rs. 2007 No 128 |
| am F2019L00573 |
r. 33.................... | rs. 2007 No. 128 |
Part 6................... | rep. 2007 No. 128 |
rr. 34-36................. | rep. 2007 No. 128 |
Part 7 |
|
r 38.................... | am 2007 No 128; F2024L01299 |
r 39.................... | am. 2006 No. 314; 2011 No. 73 |
| rs F2019L00573 |
Part 8 |
|
Part 8................... | rep. 2006 No. 314 |
| ad F2019L00573 |
Division 1 |
|
r 41.................... | rep 2006 No. 314 |
| ad F2019L00573 |
| (5) exp 8 Oct 2020 (r 41(6)) |
r 42.................... | rep. 2006 No. 314 |
| ad F2019L00573 |
r 43.................... | ad F2019L00573 |
Division 2 |
|
Division 2................ | ad F2025L00204 |
r 44.................... | ad F2025L00204 |
r 45.................... | ad F2025L00204 |
r 46.................... | ad F2025L00204 |
r 47.................... | ad F2025L00204 |
r 48.................... | ad F2025L00204 |
r 49.................... | ad F2025L00204 |
Schedule 1A |
|
Schedule 1A.............. | ad. 2006 No. 314 |
| am F2019L00573; F2025L00204 |
Schedule 1B |
|
Schedule 1B............... | ad F2019L00573 |
Schedule 1 |
|
Schedule 1................ | rs 2006 No 314 |
| am 2011 No 73; F2019L00573;F2025L00204 |
Schedule 2 |
|
Schedule 2................ | rs. 2006 No. 314 |
| am. 2007 No. 128; 2011 No. 73; F2019L00573 |
Schedule 3 |
|
Schedule 3................ | rs. 2006 No. 314 |
| am. 2007 No. 128 |
| rs. 2011 No. 73 |
| am F2019L00573 |
Schedule 4................ | rep. 2006 No. 314 |